Test Catalog

Test Id : IFXED

Immunofixation Heavy Chain Type Delta and Epsilon, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identification and isotyping of monoclonal immunoglobulin heavy (IgD and IgE) and light chains

 

Documentation of complete response to therapy

Method Name
A short description of the method used to perform the test

Immunofixation

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Immunofixation Delta and Epsilon, S

Aliases
Lists additional common names for a test, as an aid in searching

Heavy Chain proteins

Immunofixation (IEP)

Immunoelectrophoresis (IFE)

Immunosubtraction

Macroglobulins

Monoclonal protein study

Myeloma study

Protein analysis, myeloma

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: Fasting preferred but not required

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identification and isotyping of monoclonal immunoglobulin heavy (IgD and IgE) and light chains

 

Documentation of complete response to therapy

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Monoclonal gammopathies indicate a clonal expansion of plasma cells or mature B lymphocytes and rarely may consist of IgD or IgE immunoglobulin heavy chains. The monoclonal gammopathies of such diseases include: multiple myeloma, primary systemic amyloidosis, light-chain deposition disease, as well as the premalignant disorders of smoldering myeloma and monoclonal gammopathy of undetermined significance (MGUS). Monoclonal gammopathy patients may have a relatively small monoclonal protein abnormality or a large quantifiable peak (M-spike) on serum or urine protein electrophoresis.

 

Abnormalities detected on serum protein electrophoresis (SPEP) should be immunotyped to confirm and characterize the monoclonal protein. Immunotyping of monoclonal proteins is usually done by immunofixation electrophoresis (IFE), which identifies the monoclonal immunoglobulin heavy-chain (gamma, alpha, mu, delta, or epsilon) and/or light-chain type (kappa or lambda). It is generally recommended that both SPEP and IFE be used as a screening panel. Because IFE is more sensitive than SPEP, IFE is not only recommended as part of the initial screening process but also for confirmation of complete response to therapy. Patients that have only lambda or kappa light chains on traditional IgG, IgA, IgM, kappa and lambda IFE should be tested using anti sera against IgD and IgE to accurately isotype the M-protein.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Immunofixation Delta and Epsilon: No monoclonal IgD or IgE protein detected.

Immunofixation Delta and Epsilon, Flag: Negative

Interpretation
Provides information to assist in interpretation of the test results

Immunofixation impression comments are made based on visual interpretation of gels.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Immunofixation is not a quantitative assay. If a monoclonal protein is identified, a serum protein electrophoresis assay is required for quantifying the abnormality.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Willrich MAV, et al: Laboratory testing for monoclonal gammopathies: Focus on monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. Clin Biochem. 2018;51:38-47

2. Sykes E, Posey Y: Immunochemical characterization of immunoglobulins in serum, urine, and cerebrospinal fluid. In: Detrick B, Schmitz JL, Hamilton RG eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:89-100

3. Katzmann JA, Kyle RA: Immunochemical characterization of immunoglobulins in serum, urine, and cerebrospinal fluid. In: Detrick B, Hamilton RG, Folds JD eds. Manual of Molecular and Clinical Laboratory Immunology. 7th ed. ASM Press; 2006:88-100

4. Keren DF, Humphrey RL: Clinical indications and applications of serum and urine protein electrophoresis. In: Detrick BD, Hamilton RG, Schmitz JL eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. 2016:74-88

5. Katzmann JA, Keren DF. Strategy for detecting and following monoclonal gammopathies. In: Detrick BD, Hamilton RG, Schmitz JL, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:112-124

Method Description
Describes how the test is performed and provides a method-specific reference

Immunofixation is performed with Sebia reagent sets that are specific for delta and epsilon immunoglobulin heavy chains and kappa and lambda light chains. Immunofixation electrophoresis is performed in four stages: 1) separation of proteins by electrophoresis on an agarose gel; 2) immunofixation (immunoprecipitation) and fixation of the electrophoresed proteins;3) removal of unprecipitated soluble proteins by blotting and washing;, and 4) staining of the precipitated proteins for visualization.(Package insert: Sebia HYDRAGEL 1, 2, 4 and 9 IF kit. Sebia Inc; 07/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86334

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports